Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With H… (NCT06581432) | Clinical Trial Compass
RecruitingPhase 2
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
United States, Australia, Belgium430 participantsStarted 2024-10-11
Plain-language summary
This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.
Participants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.
Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
inclusion criteria:
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Patients ≥18 years old or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the Informed consent form (ICF).
* Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:
* HER2 amplification
* Known activating HER2 mutations
* Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material
* Patient with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour who has had at least one prior line of therapy for metastatic disease. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.
Further inclusion criteria apply.
exclusion criteria:
* Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)
* Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except:
* effectively treated non-melanoma skin cancers
* effectively treated carcinoma in situ of the cervix
* effectively treated ductal carcinoma in situ of the breast
* localised prostate cancer on watchful waiting or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with objective response (OR)